Drugs/Therapy

GlaxoSmithKline’s H1N1 Swine Flu Vaccine Linked to Rare Sleep Disorder in Children

By Cheri Cheng | Update Date: Feb 27, 2013 12:12 PM EST

Children may be developing a rare sleep disorder known as narcolepsy after receiving GlaxoSmithKline's Pandemrix swine flu vaccine, a new study finds. The United Kingdom scientific study discovered a relationship between this vaccine, which was administered to over 30 million people during the H1N1 pandemic between 2009-2010, and narcolepsy, a sleep disorder in which the body most commonly suffers from random daytime sleep attacks. This study reaffirmed other findings in Europe that suggested the same causal relationship.

According to the researchers at Britain's Health Protection Agency (HPA), the vaccine increased the risks by 14 times for children with a familial history of narcolepsy in developing the sleep disorder. The researchers also stated that the risk became 16 times more likely to manifest if the vaccination was administered six months prior to the onset of the disorder. The vaccine is believed to have contained a booster that could be responsible for triggering the immune reaction for children with a higher genetic risk for narcolepsy.  The specific booster that scientists are investigating is called AS03.

The study analyzed the data from 75 children between the ages of four and 18 who developed narcolepsy in England. These children were diagnosed in 2008 and had sought sleep treatments. 11 of the children were given the flu vaccine before symptoms showed up.

Narcolepsy is a life-long disorder with no immediate cure. It can cause severe night terrors, hallucinations, and an unexpected loss of muscle strength in extreme cases.

The study was published in the British Medical Journal and is linked to studies from Finland, Sweden, and Ireland. These other European nations also found more than 800 cases linking the flu vaccine to narcolepsy.

"We really want to get to the bottom of this and understand more about the potential role of Pandemrix in the development of narcolepsy," a spokesperson for the drug company stated to Reuters. "[However,] the available data are insufficient to assess the likelihood of a causal association between Pandemrix and narcolepsy."

Based from the numbers, the researchers believe that the vaccine will affect one in 50,000 cases throughout the 47 European countries that received most of the vaccine.  Other European nations estimated that 16,000-17,000 children would be affected. The vaccine was never administered in the United States. 

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